Evolution G48032Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10827002480329), received between May 19, 2016 and Apr 23, 2026 — classified as 10 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Physical Resistance/Sticking

  WHEN STENT WAS FULLY DEPLOYED , A SMALL PART OF FLANGE WAS STILL STUCK IN THE DELIVERY SYSTEM AND DID NOT DEPLOY PROPERLY EVEN AFTER THE DEPLOYMENT TRIGGER BUTTON ON THE DELIVERY SYSTEM WAS FULLY PULLED TILL THE STENT DEPLOYMENT INDICATOR CAME TO THE END OF THE DELIVERY HANDLE, THE STENT CAME OUT WITH THE DELIVERY SYSTEM. PHYSICIAN USED ANOTHER EVOLUTION STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965998 ↗
• MalfunctionApr 6, 2026Activation Failure; Physical Resistance/Sticking

  PROBLEM FOR THE STAFF WHO WERE UNABLE TO REMOVE THE PIN (GOUPILLE). CUSTOMER DID NOT ANSWER THE EMAILS FROM SSC AND SBU. BUT THEY TOLD THE SBU THAT THIS DEVICE WAS USED IN (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792698 ↗
• MalfunctionJan 16, 2025Improper or Incorrect Procedure or Method; Material Twisted/Bent; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  THE USER KNOWS THE PRODUCT VERY WELL, AFTER YEARS OF EXPERIENCE WITH IT. THEY WANTED TO RELEASE THE STENT WHEN THEY HIT THE POINT OF NO RETURN, BUT THE SECURITY WIRE WAS VERY HARD TO TAKE OUT, SO THE NURSE HAD TO USE SOME FORCE TO DO SO. AFTER THAT THEY CONTINUE TO RELEASE THE STENT AND AFTER REACHING THE END THEY TOOK OUT THE ENDOSCOPE. UNFORTUNATELY, THE STENT WASN´T RELEASED AND THEY PULLED IT OUT AGAIN. THEY ORDERED A NEW ONE TO TREAD THE PATIENT AGAIN NEXT WEEK. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THEY HAVE TO RE-DO THE PROCEDURE AS SOON AS THE STENT ARRIVES AGAIN. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THEY ARE GOING TO DO THE SAME PROCEDURE AS SOON AS THEY RECEIVE THE NEW STENT. THEY DID NOT MENTION ANY DAMAGE, BUT THE NEED OF ANOTHER PROCEDURE. 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL DURING STENT PLACEMENT, W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175682 ↗
• MalfunctionJul 30, 2024Off-Label Use; Material Twisted/Bent; Off-Label Use; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19859496 ↗
• MalfunctionSep 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  STENT CAME OUT WITH DEVICE DESPITE STYLET REMOVED AT 50% POINT. (PR 401746 / MDR REF#3001845648-2023-00584) AFTER STENT COMPLETELY DEPLOYED, DOCTOR WAS REMOVING THE DELIVERY DEVICE AND STENT ALSO CAME OUT WITH DEVICE WHILE STYLET WAS ALREADY REMOVED AT THE POINT OF 50%. 1. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? N/A, YES, NO ANS: NO. THIS FILE WILL CAPTURE USER ERROR OF THE CUSTOMER NOT INSPECTING THE DEVICE FOR DAMAGE BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789050 ↗
• MalfunctionJul 27, 2023Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 08-MAY-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404956 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). DEVICE ISSUES: TUMOUR INGROWTH (STENT). SPECIFY LOCATION: STENT NOT DETECTED. RELATIONSHIP: DEVICE; NOT RELATED, PROCEDURE; NOT RELATED. PRE-EXISTING: YES. ESOPHAGEAL TUMOUR STRICTURE. DEFICIENCY: NO. 90 DAYS POST PLACEMENT STENT INGROWTH. ENDOSCOPICALLY REMOVED AND NEW STENT PLACED (NON-STUDY STENT).

  Patient problems: Obstruction/Occlusion

  MAUDE report 16853213 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MDR- 2054 301-050 AE1 -DEVICE ISSUES: TUMOUR OVERGROWTH (STENT), SPECIFY LOCATION; MEDIUM, RELATIONSHIP: DEVICE; NOT RELATED, PROCEDURE: NOT RELATED, PRE-EXISTING: YES; TUMOUR GROWTH, DEFICIENCY: NO 180 DAYS POST STENT PLACEMENT - TUMOUR OVERGROWTH. NEW NON STUDY COOK STENT PLACED ENDOSCOPICALLY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16852894 ↗
• InjuryApr 28, 2023Migration; Migration

  SUPPLEMENT FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830476 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 25-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 16830475 ↗
• InjuryNov 4, 2022Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  HELLO, PLEASE OPEN A COMPLAINT FILE FOR CH MEAUX CFR _17703 PROCEDURE (B)(6) 2022 DECLARATION (B)(6) 2022 EVO-20-25-12,5-E C 1948699 NO PATIENT COMPLICATIONS RESCHEDULED PATIENT 11/10 ESOPHAGEAL STENT PLACEMENT FOR CARDIA STENOSIS. HASSLE-FREE SETUP AND RELEASE. THE STENT CAME BACK OUT WITH THE FLEXOR CATHETER DESPITE GOOD DELIVERY AND HAVING REMOVED THE CATHETER SEPARATION WIRE." "AS PER CC FORM": HASSLE-FREE SETUP AND RELEASE. THE STENT CAME BACK OUT WITH THE FLEXOR CATHETER DESPITE GOOD DELIVERY AND HAVING REMOVED THE CATHETER SEPARATION WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO OTHER STENT AT THE CUSTOMER - ADD PROCEDURES (B)(6). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? WHILE REMOVING THE INTRODUCER. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? GASTROSCOPE PEDIATRIC OLYMPUS. WHAT WAS THE POSITION OF THE ELEVATOR? DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? LIFE PARNER SAVARY. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731003 ↗
• MalfunctionOct 12, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE LAB EVALUATION CONDUCTED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586273 ↗
• MalfunctionFeb 2, 2022Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF A LAB EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423408 ↗
• MalfunctionJan 13, 2022Insufficient Device Problem Information; Activation Failure; Insufficient Device Problem Information; Activation Failure

  AS PER SOURCE DOC: "CUSTOMER INDICATED THAT THEY COULDN'T PLACE THE PRODUCT".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13246693 ↗
• MalfunctionSep 3, 2021Product Quality Problem; Activation Failure; Physical Resistance/Sticking; Product Quality Problem; Activation Failure; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT IS BEING SUBMITTED WITH AN UPDATE TO THE DESCRIPTION OF EVENTS ADDTIONAL INFORMATION RECEIVED 01-SEP-2021: PROCEDURE REPEATED WITH A 12.5CM AFTER TWO DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419941 ↗
• MalfunctionMay 19, 2021Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  SUPPLEMENTAL REPORT - DEVICE EVALUATED: "STENT NOT RETURNED. LOCKWIRE NOT RETURNED. HANDLE ACTUATING FINE FOR DEPLOYMENT AND RECAPTURE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846872 ↗
• MalfunctionMay 14, 2021Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Migration; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Migration

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 11825055 ↗
• MalfunctionMay 14, 2021Activation Failure; Activation Problem; Activation Failure; Activation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 11825016 ↗
• MalfunctionDec 3, 2020Off-Label Use; Improper or Incorrect Procedure or Method; Migration; Off-Label Use; Improper or Incorrect Procedure or Method; Migration

  FROM PRODUCT SPECIALISTS INITIAL EMAIL: STENT MIGRATION ¿ PATIENT NEEDS ANOTHER STENT PLACED TO COVER THE TUMOUR. RPN: (B)(4). DOCTOR NOT COMPLAINING SO MUCH AS WANTING INFORMATION ON PLACING ANOTHER STENT. COMPLAINT REPORTING FORM RECEIVED ON 11 NOV 2020 REPORTED THAT THE PATIENT HAD TUMOUR IN AND AROUND THE OGJ. SAVARY GILLARD DISPOSABLE GUIDE WIRE G57821 / SGW-250-SD-D WAS PLACED VIA GASTROSCOPE WITHOUT COMPLICATION. THE STENT WAS IMPLANTED ACCORDING TO IFU STEPS, WITH ONE DISCREPANCY, THE DISTAL FLANGE WAS POSITIONED AS CLOSE TO THE OGJ AS POSSIBLE AS THE TUMOUR SITE INVADED THE OGJ. THE SURGEON WAS MADE AWARE PRIOR TO SURGERY THAT THE STENT HAD A HIGHER THAN USUAL RISK OF MIGRATING DISTALLY AND HE WAS SATISFIED WITH THIS POTENTIAL COMPLICATION OCCURRING. THE STENT IS STILL IN PLACE AS IT IS REQUIRED. THE SURGEON HAS BOOKED ANOTHER COOK MEDICAL OESOPHAGEAL FULLY COVERED STENT TO BE DEPLOYED WITHIN THE CURRENT IN-SITU STENT ON FRIDAY (B)(6) 2020. JIL01 (B)(6) 2020. PATIENT OUTCOME: NO UNINTENDED PIECE OF DEVICE REMAINED IN THE PATIENT'S BODY. THE ORIGINAL STENT REMAINS INSITU. AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE WAS REPORTED: THE SURGEON HAS BOOKED ANOTHER COOK MEDICA

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10940360 ↗
• InjuryNov 30, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE INITIAL REPORTER: "ENDOSCOPY WAS PERFORMED, A TUMOR IS MARKED AND THEN THE WIRE GUIDE WAS INSTALLED THROUGH THE SCOPE. WITH RX THE STENT IS ADVANCED THROUGH THE WIRE GUIDE AND PLACED IN POSITION. THE PHYSICIAN BEGINS TO DEPLOY THE STENT SMOOTHLY UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE AND IT STARTED TO CAME TOGETHER BEING TRAPPED FINALLY IN THE UPPER ESOPHAGEAL SPHINCTER, THE PHYSICIAN REMOVED WITH A ALLIGATOR JAW FORCEPS. THEN A BRAND NEW STENT WAS INSTALLED WITHOUT ANY PROBLEM."

  Patient problems: No Code Available

  MAUDE report 10918256 ↗
• InjuryNov 26, 2020Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 19-MAY-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10911780 ↗
• InjuryMay 5, 2020Activation, Positioning or Separation Problem; Migration; Activation, Positioning or Separation Problem; Migration

  THE STENT WAS REMOVED AFTER PLACING BY THE GRASPING THE LOOP AT THE PROXIMAL END OF THE STENT, THE PROXIMAL END OF THE STENT DID NO REOPEN ONCE OUTSIDE OF THE PATIENT. THIS WAS QUESTIONED BY THE CUSTOMER. THE CUSTOMER WAS CONCERNED THE PROXIMAL END OF THE STENT HAD NOT FULLY OPENED. DID ANY PIECE OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED (IF APPLICABLE):. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? UNKNOWN. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? UNKNOWN. DID THE COMPLAINANT INFORM OF ANY ADVERSE EFFECT(S) ON THE PATIENT DUE TO THIS OCCURRENCE? UNKNOWN. DID THE COMPLAINANT INFORM THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECT(S)? UNKNOWN.

  Patient problems: No Information; Obstruction/Occlusion

  MAUDE report 10023307 ↗
• MalfunctionApr 29, 2020Separation Failure; Activation Failure; Separation Failure; Activation Failure

  THE STENT WAS DEPLOYED PERFECTLY AND WITHOUT ANY HINDRANCE OR PROBLEMS. THE "PIN WAS PULLED" IN THE RED SECTION AS PER IFU. THE STENT WAS CLEARLY DEPLOYED ACROSS THE DISTAL OESOPHAGEAL STRICTURE, WITH THE DISTAL END IN THE CARDIA AND PROXIMAL END APPROX 2.5 CM ABOVE THE STRICTURE. THE STRICTURE WASTE WAS VISIBLE BUT NOT SEVERE, AND WAS APPROX 5.5-6CM LONG. WE WITHDREW THE DEPLOYMENT SYSTEM AND WIRE. WE USED FLOUROSCOPY TO WATCH THE TIP OF THE DEPLOYMENT SYSTEM PULL THROUGH THE STRICTURE. THIS OCCURRED WITH NO PROBLEMS. HOWEVER, THE STENT WAS VISIBLE IN THE PATIENTS MOUTH AS THE DEPLOYMENT CATHETER WAS REMOVED. I AM COMPLETELY UNABLE TO ASCERTAIN WHY THIS HAPPENED, AS IT WAS AN EASY AND UNEVENTFUL PROCEDURE. I CAN ONLY GUESS THAT THE TIP OF THE DEPLOYMENT SYSTEM HAD SOMEHOW MANAGED TO SNAG THE PROXIMAL DRAWSTRING ON THE STENT AND PULL IT THROUGH. WE WERE ABLE TO SUCCESSFULLY AND UNEVENTFULLY PLACE ANOTHER STENT ACROSS THE STRICTURE. C5. DID ANY PIECE OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. C6. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED (IF APPLICABLE): C7. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. C8. DID THE PRODUCT CAUSE OR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10008404 ↗
• MalfunctionDec 5, 2019Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  THE PROSTHESIS WAS INTRODUCED OVER A GUIDEWIRE. AFTER POSITIONING IT IN THE IDEAL LOCATION, DEPLOYMENT STARTED. WHEN DEPLOYNG (SQUEEZE THE TRIGGER) FOR THE FIRST TIME, WE HEARD AN UNUSUAL "CRACK" AND THEN REALIZED FROM THE SCOPE THAT THE PROSTHESIS WAS NOT OPENING. WHEN REMOVING THE PROSTHESIS, IT WAS OBSERVED THAT THE TIP WAS WITH A DISRUPTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9416983 ↗
• MalfunctionNov 9, 2018Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE ¿FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED¿ AS REPORTED TO CUSTOMER RELATIONS: "'FAILED ITEM AND DESCRIPTION?'SHEATH DAMAGED. STENT WOULD NOT RELEASE AT THE END.' 'WHERE DID THE DEVICE FAIL?' ERCP2. 'ACTION OR PROCEDURE BEING PERFORMED' EGD WITH STENT. 'PERSON USING THE DEVICE WHEN IT FAILED' DR. SIDDIQUI. 'LENGTH OF TIME THE DEVICE WAS IN USE.' NOT REPORTED. 'RESULT OF THE DEVICE FAILURE' HAD TO START OVER WITH STENT PLACEMENT. ADDITIONAL DETAILS PROVIDED BY DM ON 16OCT2018: "PATIENT HAD A GE JUNCTION TUMOR. PLACING ESOPHAGEAL STENT IN THE GE JUNCTION, PATIENT ANATOMY WAS ANGULATED AND TIGHT TO GET THROUGH. PHYSICIAN HAD TO PUT .035 GLIDE WIRE THROUGH STRICTURE. STENT WOULD NOT MAKE THE TURN, KINKING AT TIP OF INTRODUCER (DISTAL END). CUSTOMER UNWILLING TO DEPLOY IT AT THIS POINT. CUSTOMER TOOK IT OUT AND PUT IN A BOSTON SCIENTIFIC DEVICE TO COMPLETE PROCEDURE SUCCESSFULLY." ADDITIONAL DETAILS PROVIDED BY DM ON 19OCT2018: "[THIS EVENT] OCCURRED WHEN TRYING TO PASS THE STENT OVER A PROPOSITIONED 035 VISIGLIDE WIRE INSIDE THE PATIENT. BEFORE DEPLOYMENT COULD NOT GET STENT INTO POSITION. [THE CUSTOMER USES] OLY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054301 ↗